Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial).

西奈山的 COFAR 临床研究单位和临床试验（“ADVANCE”试验）。

• 批准号: 10399723
• 负责人: SCOTT H SICHERER
• 金额: $ 23.5万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-05 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10399723
• 关键词: Mount; Sinai; COFAR; Clinical; Research

MOUNT SINAI’S CoFAR CLINICAL RESEARCH UNIT AND CLINICAL TRIAL (THE “ADVANCE” TRIAL) Food allergy affects up to 8% of children and approximately 5% of adults, is a significant burden on quality of life, is costly, and can be fatal. Significant advances have been made in identifying potential treatment and prevention strategies. Oral (OIT), sublingual (SLIT), and epicutaneous (EPIT) immunotherapy, as well as combination therapy using OIT and omalizumab, and simply having children who are reactive to egg or milk ingest extensively heated forms if they can, have all shown promise to improve treatment. However, limitations of these approaches, including variable efficacy, side effects, costs, and lack of sustained unresponsiveness off treatment frame the need for better therapies. Exciting advances in prevention, specifically the efficacy of early introduction of peanut, have been recently noted. However, more needs to be done to identify the most effective prevention strategies. The objectives of the Consortium for Food Allergy Research (CoFAR) are to conduct ground-breaking trials and studies in treatment and prevention of food allergy, and to incorporate mechanistic studies. The long-term goals of CoFAR are to develop effective strategies to prevent and treat food allergies, and to elucidate underlying immunologic mechanisms. The major objective of the Mount Sinai CoFAR Clinical Research Unit (CRU) is to provide CoFAR with outstanding study opportunities and to propose a clinical trial to achieve the above stated goals. The Mount Sinai CRU team has been successfully and safely conducting food allergy research since 1997. It has contributed to every interventional study described above, and has an extensive portfolio of additional clinical studies. The CRU PI, Scott Sicherer, MD, brings broad experience having been site PI for all of the past CoFAR interventional trials, as well as being Protocol Chair of the CoFAR observational clinical study. He also brings extensive experience from a myriad of areas of food allergy research, including additional treatment trials, registries, diagnostics, and performing quality of life and epidemiologic research and has been a mentor to numerous food allergy investigators. Co-Investigators Drs. Wang and Bunyavanich have served as successful PIs on clinical trials. Two early stage investigators are on the team and will benefit from their involvement to become the next generation of leaders in food allergy research. The Mount Sinai laboratory facilities have been the biomarker core for CoFAR and other multicenter studies and can easily manage biological samples at the direction of the Leadership Center (LC). The Mount Sinai CRU is located in Manhattan, with access to an extensive base of potential participants; it has safely conducted >20,000 oral food challenges and has a superb record of study recruitment and retention. To increase opportunities to contribute to CoFAR’s goals, a clinical trial is proposed using a novel experimental product that combines low dose food allergen with an adjuvant (enhancing a favorable immune response). In summary, the Mount Sinai CoFAR CRU brings extensive resources and experience to ensure that the goals of CoFAR, at the direction of the LC, Steering Committee and NIAID, are met.

西奈山的 CoFAR 临床研究单位和临床试验（“高级”试验） 食物过敏影响高达 8% 的儿童和约 5% 的成人，对食品质量造成重大负担 生命是昂贵的，并且可能是致命的。在确定潜在治疗方法和治疗方法方面已取得重大进展 预防策略。口服 (OIT)、舌下 (SLIT) 和经皮 (EPIT) 免疫疗法，以及 使用 OIT 和奥马珠单抗的联合疗法，以及简单地生出对鸡蛋或牛奶有反应的孩子 如果可以的话，摄入高度加热的形式，都显示出改善治疗的希望。然而，局限性 这些方法的影响，包括不同的功效、副作用、成本以及缺乏持续无反应的情况 脱离治疗框架需要更好的治疗方法。预防方面取得了令人兴奋的进展，特别是其功效 花生的引进很早，最近才被注意到。然而，还需要做更多的工作来确定最 有效的预防策略。食物过敏研究联盟 (CoFAR) 的目标是 在食物过敏的治疗和预防方面进行突破性的试验和研究，并将 机理研究。 CoFAR 的长期目标是制定有效的策略来预防和治疗 食物过敏，并阐明潜在的免疫机制。西奈山的主要目标 CoFAR临床研究单位（CRU）将为CoFAR提供出色的学习机会并提出 为实现上述目标而进行的临床试验。西奈山 CRU 团队已成功且安全地 自 1997 年起进行食物过敏研究。它对上述每一项干预研究都有贡献， 并拥有广泛的额外临床研究组合。 CRU PI，医学博士 Scott Sicherer 带来了广泛的 拥有作为过去所有 CoFAR 介入试验的现场 PI 的经验，以及担任 CoFAR 观察性临床研究。他还带来了食品各个领域的丰富经验 过敏研究，包括额外的治疗试验、登记、诊断和生活质量评估 流行病学研究，并一直是许多食物过敏研究人员的导师。共同研究人员博士。 Wang 和 Bunyavanich 曾担任临床试验的成功 PI。两名早期研究人员正在进行 团队并将受益于他们的参与，成为下一代食物过敏领域的领导者 研究。西奈山实验室设施已成为 CoFAR 和其他多中心的生物标志物核心 研究并可以在领导中心 (LC) 的指导下轻松管理生物样本。山 西奈 CRU 位于曼哈顿，拥有广泛的潜在参与者基础；它已经安全地 进行了超过 20,000 次口服食物挑战，并拥有出色的研究招募和保留记录。到 为了增加为 CoFAR 目标做出贡献的机会，建议使用一种新颖的实验进行临床试验 将低剂量食物过敏原与佐剂（增强有利的免疫反应）相结合的产品。在 总之，西奈山 CoFAR CRU 带来了丰富的资源和经验，以确保实现 CoFAR 在 LC、指导委员会和 NIAID 的指导下召开会议。